|
Device | TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S063 |
Date Received | 06/08/2011 |
Decision Date | 07/07/2011 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC). |